Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
  • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
  • A61J1/14—Details; Accessories therefor
  • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
  • A61J1/2089—Containers or vials which are to be joined to each other in order to mix their contents
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
  • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
  • A61J1/14—Details; Accessories therefor
  • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
  • A61J1/2093—Containers having several compartments for products to be mixed
• • B—PERFORMING OPERATIONS; TRANSPORTING
  • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
  • B65D—CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
  • B65D25/00—Details of other kinds or types of rigid or semi-rigid containers
  • B65D25/02—Internal fittings
  • B65D25/04—Partitions
  • B65D25/08—Partitions with provisions for removing or destroying, e.g. to facilitate mixing of contents
  • B65D25/082—Partitions with provisions for removing or destroying, e.g. to facilitate mixing of contents the partition being in the form of a plug or the like which is removed by increasing or decreasing the pressure within the container
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
  • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
  • A61J1/05—Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
  • A61J1/10—Bag-type containers
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
  • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
  • A61J1/14—Details; Accessories therefor
  • A61J1/1475—Inlet or outlet ports
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
  • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
  • A61J1/14—Details; Accessories therefor
  • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
  • A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
  • A61J1/2006—Piercing means
  • A61J1/201—Piercing means having one piercing end
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
  • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
  • A61J1/14—Details; Accessories therefor
  • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
  • A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
  • A61J1/202—Separating means
  • A61J1/2031—Separating means having openings brought into alignment
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
  • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
  • A61J1/14—Details; Accessories therefor
  • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
  • A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
  • A61J1/2048—Connecting means
  • A61J1/2051—Connecting means having tap means, e.g. tap means activated by sliding
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
  • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
  • A61J1/14—Details; Accessories therefor
  • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
  • A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
  • A61J1/2048—Connecting means
  • A61J1/2058—Connecting means having multiple connecting ports
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
  • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
  • A61J1/14—Details; Accessories therefor
  • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
  • A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
  • A61J1/2048—Connecting means
  • A61J1/2058—Connecting means having multiple connecting ports
  • A61J1/2062—Connecting means having multiple connecting ports with directional valves
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
  • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
  • A61J1/14—Details; Accessories therefor
  • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
  • A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
  • A61J1/2068—Venting means
  • A61J1/2075—Venting means for external venting
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
  • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
  • A61J1/14—Details; Accessories therefor
  • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
  • A61J1/2096—Combination of a vial and a syringe for transferring or mixing their contents
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
  • A61J2205/00—General identification or selection means
  • A61J2205/30—Printed labels
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
  • A61J7/00—Devices for administering medicines orally, e.g. spoons; Pill counting devices; Arrangements for time indication or reminder for taking medicine
  • A61J7/0015—Devices specially adapted for taking medicines
  • A61J7/0038—Straws
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
  • A61J7/00—Devices for administering medicines orally, e.g. spoons; Pill counting devices; Arrangements for time indication or reminder for taking medicine
  • A61J7/0015—Devices specially adapted for taking medicines
  • A61J7/0053—Syringes, pipettes or oral dispensers

Definitions

• the present invention relates to a single compartment storage and transfer bottle designed to store a component of a drug substance and to transfer it directly, or after having mixed it with another substance, in a device for use, this bottle comprising an open narrowed neck and a closure device engaged in this neck.
• Medicinal substances whether directly usable or whether they constitute the components of a mixture, are usually stored in containers which can either be flame-sealed glass ampoules or vials sealed with a stopper. shutter.
• a bottle of this type is for example described by US Patent No. 3,674,028 and comprises a body provided with a narrowed neck and a central constriction which defines two compartments respectively containing a lyophilisate and a solvent intended to be mixed.
• the neck is closed by a special plug allowing the evacuation of the vapors during the lyophilization of the substance deposited in the lower compartment. After lyophilization, the plug is pushed back into the central zone of the body comprising the constriction and thus separates the two compartments in a leaktight manner.
• a shutter is placed at the end of the neck to close the upper compartment after filling it.
• This obturator comprises a central zone of lesser thickness, intended to be pierced by a needle for the purpose of withdrawing the mixture to be injected from a patient.
• a liquid medicinal substance pose a significant problem during the transfer of their contents into a device for use such as a syringe.
• the caregiver must, in all cases, use a needle to draw up the liquid from the ampoule.
• the needle used to carry out the transfer is contaminated on its outer walls by the drug solution. This external contamination of the needle is responsible for pain, bruising or other tissue damage which should not in principle be in contact with the drug substance.
• the transfer does not prevent bacterial and particulate contamination. Due to hygienic rules, the transfer needle is not to be reused and replaced with a new sterile needle, and this for each transfer operation.
• Transfer set which has a double needle or a double trocar, and which is used to directly connect a vial closed by an elastomer stopper with a pocket or an infusion bottle.
• the bottle may contain a liquid or dry drug substance.
• the transfer device is however supplied independently of the bottle to which it is supposed to connect, and presented in sterile packaging. Therefore, nothing prevents its reuse on another bottle after a first use, even if the rules of hospital hygiene prohibit such reuse.
• the only way to prevent both handling errors during the installation of a transfer device and its reuse, is to provide a bottle equipped with a non-removable transfer device.
• the present invention proposes to overcome the above drawbacks by providing a storage bottle which can be connected to all kinds of receptacles or containers on the market, without any noticeable increase in the cost of manufacture and without technical complications,
• the bottle according to the invention is characterized in that the closure device is designed to be moved between a first position, called storage, in which it constitutes a sealed shutter, and a second position, called use, in which it constitutes an open valve to allow the evacuation of said medicinal substance, and in that this device is integral with a device for connecting the vial with a container containing another component of the medicinal substance and / or with the device of use.
• the closure device may comprise a flexible elastomeric closure member comprising a central cavity and a radial channel opening into the central cavity, it may be mounted on a capsule fitted to the neck of the bottle and axially movable between said storage position and said use position.
• the capsule is provided with a conical connecting tip and a stiffening element engaged inside a cavity of the 'closure member.
• connection end piece may be a "Luer” type end piece or may be a “Luer Lock” type end piece.
• connection end piece is a male conical end piece or a female conical end piece.
• connection endpiece carries a needle and the capsule is provided with a substantially cylindrical protective element whose length is at least approximately equal to that of the needle.
• the bottle has connecting means for flexibly binding it to the device for use or to another container containing another component of the drug substance.
• Said connecting means preferably comprise a lace, the ends of which are equipped with locking connecting elements.
• the bottle comprises at least one filter mounted in the connection device or the closure device, in a zone of obligatory passage of the drug substance or of the mixture of this substance with another substance before its use.
• this filter is of the membrane filter type.
• the closure device When said device is in its first so-called storage position, the closure device can be linked to the bottle by a tamper-evident label.
• said needle has at least one lateral opening arranged to allow the evacuation of an overpressure generated inside the bottle and / or of another container connected to the bottle by means of said needle.
• the closure device may include a vent and an elastic closure element arranged to close said vent in a first position and to release it in a second position.
• said vent is formed in a wall of the capsule and the closure device carries a hydrophobic filter disposed over said vent.
• this hydrophobic filter has an annular shape and has a central opening which ensures communication between the closure device and the connection device.
• the closure device consists of two separate parts, a head and an annular seal.
• the head and the annular seal are made of different materials.
• FIGS. 1 to 5 illustrate the process of filling a flask containing a compound in the lyophilisate state
• FIGS. 6 to 9 illustrate the process of filling a bottle containing a powder intended to be mixed with a liquid solvent
• FIG. 10 shows another embodiment of a bottle according to the invention
• FIG. 15 represents a perspective view of a closure member intended for a lyophilization bottle
• FIG. 17 represents a bottle according to the invention coupled to a peristatic pump
• FIG. 18 represents a bottle fitted with a mouthpiece
• the ' Figure 19 shows a sectional view of a bottle according to the invention attached to a prefilled syringe
• FIG. 20 represents a sectional view of a bottle coupled to a traditional syringe
• FIG. 21 represents a sectional view of a bottle equipped with a needle and connected to an infusion bag
• FIG. 22 shows a sectional view of a bottle according to the invention coupled to a flexible bottle
• FIG. 23 represents a sectional view of a bottle according to the invention connected to a three-way valve
• FIG. 24 represents a sectional view illustrating the storage position of a bottle according to the invention equipped with a needle
• FIG. 25 represents a sectional view of a bottle according to the invention equipped with a connection device of the Luer-Lock type and protected by a cap
• FIG. 26 represents a particular embodiment of a bottle intended to be coupled to an infusion bag
• FIG. 27 represents a sectional view of another embodiment making it possible to release an overpressure inside the bottle and / or a pocket
• FIG. 28 represents a sectional view illustrating the bottle of FIG. 27 in its use phase
• FIG. 29 represents a variant of the embodiment of FIGS. 27 and 28, and
• FIG. 30 represents an enlarged sectional view illustrating more specifically the hydrophobic filter mounted inside the obturation member.
• a bottle 10 provided with a closed bottom 11 and an open neck 12 with a narrowed section relative to that of the body 13 of the bottle, is partially filled with a liquid substance 14 which is introduced at the interior of the bottle through a conduit 15.
• the liquid 14 is in this case an aqueous solution of a medicinal substance intended to be lyophilized.
• the freeze-drying phase is shown in fig. 2.
• This operation is carried out inside a device essentially comprising an enclosure connected to a vacuum pump and cryogenic means.
• the bottle 10 Before entering this enclosure, the bottle 10 is equipped a flexible closure member 16, made of elastomer, which comprises at its lower end a nozzle 17, integral with the upper part of this member and provided with at least one lateral opening 18 allowing the steam 19 to escape out of the bottle.
• a flexible closure member 16 made of elastomer, which comprises at its lower end a nozzle 17, integral with the upper part of this member and provided with at least one lateral opening 18 allowing the steam 19 to escape out of the bottle.
• the obturation member * is sterile at the time of its installation on the neck of the bottle and the enclosure. of lyophilization is a sterile enclosure.
• FIG. 3 The next phase which consists in putting the obturation member in its storage position, is represented by FIG. 3.
• a pusher 20 disposed inside the lyophilization enclosure.
• the shutter member 16 is provided with a radial channel 21 which is closed by the wall of the neck of the bottle in the position represented by this figure.
• this pusher is constituted by the ceiling of the freeze-drying enclosure. According to other embodiments, the ceiling of the freeze-drying enclosure is fixed and it is the floor supporting the bottles which moves upwards to cause the penetration of the closure member inside the neck .
• the tip 17 is engaged inside the bottle and the upper part of the closure member is engaged inside the neck 12 so that a radial channel 21, formed in the upper part of the shutter member, or closed by the inner wall of the neck 12.
• the closure member assumes one of its functions which is to ensure the tight closure of the bottle 10 during storage of the latter.
• the vial containing the drug substance in the lyophilized state, and sealed in sealing form by the obturating member 16 is extracted from the lyophilization enclosure and is equipped with a capsule.
• the capsule 22 which constitutes, with this closure member 16, a closure device for the bottle and serves as a support for a transfer device intended for connecting the bottle 10 with a device for use (not shown).
• the capsule 22 comprises a connection end piece 23, the shape of which is conical, and which constitutes an end piece of the so-called "Luer” type.
• This nozzle is extended towards the inside of the bottle by a stiffening element 24, of substantially cylindrical shape, which is engaged in an internal cavity 25 of the shutter member 16.
• the capsule 22 comprises a peripheral flange 26 which is engaged over the rim 27 of the neck 12 of the bottle 10, and which has internal protuberances 28 which have the purpose of cooperating with the rim 27 to define, on the one hand the storage position, and on the other hand the position of use of the transfer device and consequently of the shutter member 16.
• This transfer device proper is covered, during the storage phase, by a cap 29 which is adapted to the shape and dimensions of the various components of the capsule and in particular of the collar 26.
• a cap 29 which is adapted to the shape and dimensions of the various components of the capsule and in particular of the collar 26.
• the end piece connection is adapted to the shape and dimensions of the various components of the capsule and in particular of the collar 26.
• the capsule 22 is extended on the side opposite to the bottle by a substantially cylindrical structure 32 whose length is approximately equal to that of the needle with its needle holder.
• the cap 29 is enveloping at the level of the neck of the bottle and at the level of the flange of the capsule.
• it comprises a first sector 29a of narrowed section which essentially envelops the structure 32 of the capsule, an intermediate sector 29b which bears against the external wall of the flange 26 and a flange 29c whose external diameter is substantially equal to the external diameter of the bottle 10.
• This embodiment makes it possible to set up a tamper-evident label 33 which of course serves to identify the product but also to make the cap 29 and the bottle 10 integral.
• the installation phase of this tamper-evident label is schematically represented by the arrows B.
• the bottle described above and the filling and assembly phases illustrated in FIGS. 1 to 5 correspond to the use of a medicinal substance initially found in the form of a liquid solution and which is intended to be stored in the container. state of lyophilisate.
• a medicinal substance initially found in the form of a liquid solution and which is intended to be stored in the container. state of lyophilisate.
• the capsule is pressed onto the neck, which has the effect of * making the upper part of the closure member penetrate towards the inside of the bottle into a position where the lateral orifice 21 formed in the upper part of the closure member opens out inside the bottle and allows the needle and the interior space of the bottle to be placed in communication.
• the connection with another sterile enclosure containing the solvent is made through the needle 30.
• the sterile enclosure containing the solvent is a flexible bag or another suitable container.
• the described bottle can be connected to all devices on the market equipped with the same type of standardized Luer or Luer Lock connection, corresponding to a cone connection equipped with a locking system, namely : an empty syringe, a pre-filled syringe, a tap to connect to another container or to a conduit, a tubing, a peristaltic pump, an inhaler, a flexible infusion bag, a collapsible flexible bottle for ocular application.
• FIG. 6 represents a bottle 10 intended to allow the storage of a powder 40 introduced into this bottle through a supply tube 41.
• the bottle 10 represented by FIG. 6 is in all points identical to the bottle 10 represented by FIGS. 1 and following.
• the next phase consists in closing the bottle by means of a closure member 42 represented by FIG. 7.
• This closure member differs from that represented by the Figures 2 to 5 in that it does not include the lower tip 17 whose function is strictly linked to the lyophilization phase.
• this obturation member also comprises a radial duct 43 which makes it possible, during use, to ensure communication with the interior of the bottle 10.
• FIG. 8 The phase represented by FIG. 8 and which corresponds to the installation of the obturation and transfer devices is in all points identical to that illustrated by FIG. 4, apart from the fact that, in one, of the cases , the content of the bottle is a powder, and in the other case it is a lyophilisate. For this reason, the reference numbers of the various constituent elements are the same in both cases.
• FIG. 9 which illustrates the phase of fitting a tamper-evident label, is identical to FIG. 5 with the same difference as above. For this reason, the reference numbers of these two figures are identical.
• the syringe needle which is mounted on the connection end of the connection device, allows a solvent arranged to dissolve the powder contained in the vial to enter.
• FIG. 10 illustrates a variant of the connection device described above.
• This device connection 50 is associated with a closure member 42 identical to that which is represented by FIGS. 6 to 9 in association with the bottle containing a powder.
• the connection device 50 could also be associated with a sealing member 16 such as that shown in Figures 2 to 5 in combination with a bottle containing a lyophilisate.
• This connection member comprises a capsule 51 provided with a collar 52 which passes over the rim 27 of the neck 12 of the bottle 10.
• This collar which is shown in its position of use, has, as previously, internal protuberances 28 intended to cooperate with the rim 27 to define the storage and use positions.
• This capsule is provided with the cylindrical end piece 24 (identical to that defined in FIG.
• connection end piece 53 which is a conical female end piece with lock commonly called “Luer Lock”.
• This end piece is closed by a cap 54 provided with an internal thread 55 which is screwed onto the connection end piece 53.
• a filter 57 is placed inside the axial channel for passage of the liquid.
• This filter can be mounted in all capsules of the ' embodiments shown in the previous figures. It will be noted that this filter is preferably of the membrane filter type.
• connection with a male Luer or Luer Lock type connector is made after unscrewing the cap 54.
• the link system must meet the following requirements:
• the cap of the bottle 10 shown in Figures 11 and 12 is equipped with a passage 61 for a lace 60.
• the pharmacist can pass a lace 60 in the passage 61 formed on the head of the protective cap of the bottle, then pass this lace through one of the passages 62 provided in the infusion bag 63 (for example in the passage provided for hanging the bag), then irreversibly tie the two ends 64 and 65 of the lace.
• Such synthetic laces, equipped with an irreversible closure system are available on the market.
• a special "lace" associated with a plate 66 intended to receive inscriptions such as patient name, bed number, date and other information may be provided in the packaging of the bottle.
• the caregiver will be able to carry out a complete verification of the medication. Then it will separate the protective cap from the bottle. The protective cap will remain linked to the pocket by the lace. A part of the pasted label remaining attached to the cap will contain the "coded" information allowing the identification, by the nursing staff, of the medicament contained in the pocket.
• the vial equipped with the needle is activated then its content is dissolved and transferred to the pocket. Then the caregiver removes the bottle and separates it from the pocket.
• the two devices If the two devices are not used, they return to the pharmacy. It will be enough to cut the lace and reintroduce the material in store.
• the bottle described above responds in all. -point -to the constraints imposed in terms of conservation and use of medicinal substances. It is inviolable. It has a blocking system which makes it inactivable during storage. It includes a transfer device secured to the actual bottle which is stable and does not fear pressure or radial stress. It guarantees the sterility of the contents and the interior space including the volumes of the transfer device which are placed in communication with the interior space in the bottle at the time of use.
• the lock due to the tamper-evident label and the security system during storage is eliminated with a single gesture.
• Activation of the bottle and its transfer device is carried out in a simple manner, without effort, and without piercing a closure cap. Activation is irreversible and there is no way to allow return to the storage position. This activation can be done without external equipment, next to the patient. The transfer takes place in a vacuum, without contact with the outside.
• the coupling of the bottle and another container is carried out by means of standard members whose characteristics are perfectly known.
• FIG. 13 illustrates a mode of coupling of a bottle 10 with an infusion bag 70 provided with a connection conduit 71 composed of a narrow section 71a and a wide section 71b.
• the connection device of the bottle allows the coupling by screwing of a nozzle 72.
• the connection pipe 71 contains a sealing plug 73 which, when it is in the narrow section 71a, closes this pipe and when it found in the wide section 71b household a peripheral passage 74 between it and the wall. of the conduit.
• FIG. 14 illustrates a bottle 10 associated with a closure device and a connection device comprising a closure member 80, a capsule 81 and a needle 82, mounted on the neck 12 of this bottle.
• the needle 82 is made in one piece with the capsule 81.
• FIG. 15 represents a perspective view of the shutter member 16 which has been shown seen in section in Figure 2.
• This closure member comprises an upper part 16a and a nozzle 17 which extends this upper part.
• the end piece 17 includes, in the embodiment shown, four lateral recesses 18 which intervene during the lyophilization phase.
• the upper part 16a comprises a radial duct 21 which communicates with the outside via a substantially circular opening formed in the central zone of this upper part 16a, between two beads 16b and 16c respectively.
• FIG. 16 represents the closure member 42 which is used when the bottle 10 is intended to contain a powdery or liquid substance and not a lyophilisate.
• This shutter member is shown in section in FIG. 7. It comprises an upper part 42a which is identical in all points to the upper part 16a of the shutter member 16. In particular it is provided with a radial channel 43 which opens into a central zone delimited by two beads 42b and 42c respectively.
• a lower tip 42d of slightly frustoconical shape, extends the upper part of the shutter member. Note that this tip has no side opening.
• FIG. 17 illustrates a particular use of the bottle 10 connected via a flexible pipe 90 to a peristaltic pump 91.
• the capsule 92 is equipped with a connection end piece 93 which is coupled to a member for connection 94 to perform a Luer-Lock type coupling.
• the capsule 100 is provided with a nozzle 101 comprising no connection member to another device but which is intended to be put in the mouth by the patient.
• the bottle 10 is designed to contain a drug substance to be absorbed orally.
• FIG. 19 illustrates another use of the vial 10, which in this case is coupled to a pre-filled syringe 110.
• the capsule 111 of the closure device comprises an end piece 112 which is identical to the end piece 93 shown in FIG. 17.
• the pre-filled syringe 110 is coupled to the tip 112 by a connecting member 113 fixed to said tip by locking means of the Luer-Lock type.
• the connection member 113 includes an internal cavity 114 whose diameter is somewhat greater than the diameter of a closure plug 115 which closes the end of the syringe 110.
• FIG. 20 represents a coupling of the vial 10 with a traditional syringe 120 which can be empty or pre-filled.
• the coupling of these two components is of the Luer type.
• the capsule 121 of the closure device comprises a conical female tip 122 intended to receive a frustoconical tip 123 which is in fact the needle-holder tip of the syringe 120.
• the connection is made by means other than the needle intended to inject a substance into the patient, so that the needle is not contaminated during the transfer phase of the substances to be injected.
• FIG. 21 illustrates another embodiment of the bottle as well as another mode of use of this bottle.
• the bottle 10 is coupled to a transfusion bag 130 which comprises a connection tube 131 closed by a cap 132 made of a flexible elastomeric substance.
• the bottle is equipped with a transfer device which includes a needle 133 mounted on a needle holder 134 which fits on a nozzle 135 integral with the capsule 136. All these elements are protected by a tubular member 137, substantially cylindrical, integral with the capsule 136.
• the liquid substance contained inside the transfusion bag 130 can be transferred inside the said bottle then the mixture obtained can be transferred from the bottle to the bag 130.
• FIG. 22 illustrates another form of use of the bottle 10 which is, in this case, coupled to a flexible bottle 140 by means of a device of the Luer-Lock type 141.
• FIG. 24 represents the bottle 10 corresponding to the use illustrated by FIG. 21 in its storage position.
• the capsule 136 is surrounded by a protective cap 138 and it is linked to the bottle by a tamper-evident label 139.
• FIG. 25 represents the bottle 10 illustrated in particular by FIG. 22 and FIG. 23 in its position of storage.
• the capsule 150 is completely covered by a protective cap 151 linked to the bottle by a tamper-evident label 152.
• the closure member 153 engaged in the neck of the bottle 10 is made in two parts, a part 154, or head, which is in contact with the substance contained in the bottle and an annular seal 155 which will not be in contact with the drug substance or solution obtained after mixing with another substance, only for a short period of time. Therefore, the two parts can be made of different materials, the head is of course made of a material compatible with the substance contained in the bottle. This principle of realization can be applied to all the bottles.
• FIG. 26 illustrates another embodiment particularly suitable for the use of medicaments containing bicarbonate and or citric acid or other chemical substances which, when dissolved, generate a significant release of carbon dioxide.
• the pressure inside the entire system increases significantly. Since carbon dioxide dissolves relatively quickly in a solution, it would be possible to wait a few minutes before proceeding to infusion, nevertheless it is particularly advantageous to be able to remove this gas by a simple and effective means.
• This means comprises at least one lateral opening made in the needle 161.
• this needle has two openings 162 which are closed when it is sufficiently pressed inside the 'sealing plug 163 which closes the conduit 164 of the infusion bag 160 and which are released as shown in the figure, when it is somewhat set back from this plug.
• Figures 27 and 28 illustrate another embodiment of a vial equipped with a transfer device to ensure rapid evacuation of the carbon dioxide released during the reconstitution of a drug solution from 'a solvent and a powder initially placed in the bottle.
• Figure 27 shows an intermediate position between the storage position and the activated position of the bottle and Figure 28 shows the activated position of this bottle.
• a protective cap completely covering the capsule was removed.
• the capsule provides an opening which makes it possible to put the interior of the system in communication with the exterior.
• the capsule 170 has an opening 171 which provides communication re in the cavity 172 formed inside the body 'shutter 173 and the outside.
• a complementary element 174 which is engaged on the needle-holder endpiece 175 temporarily obtains the closure of this opening 171.
• Figure 28 shows the device in working condition.
• the operator presses as shown by the arrows M on the branches of the element 174 it releases the opening 171 and allows the evacuation of the gas under pressure inside the pocket and the bottle.
• This achievement allows to evacuate the overpressure due to carbon dioxide which is released during the preparation of an antibiotic solution.
• a simple push exerted for example by means of the thumb and the index on the elastic branches of the element 174 achieves the desired goal.
• FIG. 29 illustrates a variant of the device represented by FIG. 28.
• the modification consists in inserting a hydrophobic filter 180 inside the cavity 172, this filter being perforated in its center so as to allow a direct passage of the liquids between the bottle and pocket 181, but being arranged to cover the opening 171 which serves as a vent.
• the role of the filter is to avoid the risk of release of aerosols of antibiotics or antimitotics which are very harmful to the nursing staff.
• the advantage of the presence of the hydrophobic filter is that it makes it possible at all times to ensure the release of the overpressure without risking causing aerosols which, as mentioned above, are particularly harmful to the nursing staff.

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• Health & Medical Sciences (AREA)
• Pharmacology & Pharmacy (AREA)
• Life Sciences & Earth Sciences (AREA)
• Animal Behavior & Ethology (AREA)
• General Health & Medical Sciences (AREA)
• Public Health (AREA)
• Veterinary Medicine (AREA)
• Engineering & Computer Science (AREA)
• Mechanical Engineering (AREA)
• Medical Preparation Storing Or Oral Administration Devices (AREA)
• Closures For Containers (AREA)
• Packages (AREA)

Priority Applications (3)

Applications Claiming Priority (4)

Publications (1)

Family

ID=25694169

Family Applications (1)

Country Status (8)

Cited By (4)

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Citations (8)

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• 1989
  • 1989-12-22 CA CA 2006584 patent/CA2006584C/en not_active Expired - Fee Related
  • 1989-12-27 AT AT90900747T patent/ATE93382T1/de not_active IP Right Cessation
  • 1989-12-27 JP JP2500943A patent/JPH0669474B2/ja not_active Expired - Lifetime
  • 1989-12-27 EP EP19900900747 patent/EP0406374B1/de not_active Expired - Lifetime
  • 1989-12-27 DE DE1989608700 patent/DE68908700T2/de not_active Expired - Lifetime
  • 1989-12-27 WO PCT/CH1989/000224 patent/WO1990007318A1/fr active IP Right Grant
  • 1989-12-27 ES ES90900747T patent/ES2045897T3/es not_active Expired - Lifetime
• 1993
  • 1993-10-18 US US08/138,878 patent/US5487737A/en not_active Expired - Lifetime

Patent Citations (8)

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